PICO 66022002Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 05000223492175), received between Jun 17, 2020 and Jun 29, 2021 — classified as 1 injury, 9 malfunctions.

The most frequently reported specific device problem is “Pumping Stopped” (6 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT, UPON INSERTION OF THE BATTERIES, A PICO 7 10CMX30CM WAS NOT ABLE TO START PUMPING AND ALL LIGHTS ILLUMINATED. IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVED DURING THIG ADVERSE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12089576 ↗
• MalfunctionMar 2, 2021Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT, A GRAFT WAS PLACED, A NON-ADHERENT, THEN PICO DEVICE. THE DEVICE ACHIEVED A SEAL, AND THEN SHORTLY AFTER, ALL 4 LIGHTS TURNED ON AND STAYED ON. THE TREATMENT WAS COMPLETED WITHOUT DELAY USING A COMPETITOR DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11402579 ↗
• MalfunctionOct 7, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT ALL OF THE PICO 7 DEVICE'S LIGHTS TURNED ON SOLID AS SOON AS BATTERIES WERE PLACED IN THE PUMP. IT IS UNKNOWN WHEN THE EVENT HAPPENED, IF A PATIENT WAS INVOLVED, HOW THE TREATMENT WAS COMPLETED NOR IF THERE WAS A DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10645334 ↗
• MalfunctionJul 30, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT WHEN THE PICO PUMP WAS ASSEMBLED, ALL THE PICO LIGHTS WENT ON AND THE PICO WAS THEN INOPERABLE. ANOTHER PICO PACKAGE HAD TO BE OPENED AFTER THE FACT TO REPLACE THE BROKEN PICO. NO HARM OR INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10347785 ↗
• MalfunctionJul 15, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT ALL LIGHTS WENT ON AND THE DEVICE DID NOT WORK AT ALL, RIGHT OUT OF BOX MALFUNCTION. IT IS UNKNOWN IF THERE WAS A PATIENT INVOLVED AND HOW WAS THE EVENT SOLVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10280074 ↗
• MalfunctionJun 30, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING TREATMENT THE DEVICE MALFUNCTIONED, ALL THE LIGHTS LIGHTED UP AND THERE WAS NO SEAL/GREEN OK LIGHT. THE ISSUE WAS SOLVED WITH A BACKUP DEVICE AND THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213790 ↗
• MalfunctionJun 30, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT 3 PICO KITS OUT OF THE SAME PACK WITH THE SAME LOT NUMBER FAILED. RIGHT OUT OF THE BOX ALL LIGHTS LIGHTED UP AND IT WAS NOT POSSIBLE TO GET A SEAL WITH THE GREEN OK LIGHT. A BACKUP WAS AVAILABLE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213785 ↗
• MalfunctionJun 30, 2020Suction Failure; Suction Failure

  IT WAS REPORTED THAT DURING TREATMENT THE DEVICE MALFUNCTIONED, ALL THE LIGHTS LIGHTED UP AND THERE WAS NO SEAL/GREEN OK LIGHT. THE ISSUE WAS SOLVED WITH A BACKUP DEVICE AND THERE WAS NO INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10213776 ↗
• MalfunctionJun 18, 2020Defective Device; Defective Device

  IT WAS REPORTED THAT THE PICO KIT FAILED. RIGHT OUT OF THE BOX ALL LIGHTS LIGHTED UP AND IT WAS NOT POSSIBLE TO GET A SEAL WITH THE GREEN OK LIGHT. IT IS UNKNOWN WHETHER THE EVENT HAPPENED DURING SURGERY AND IF THERE WAS PATIENT INVOLVEMENT. IT IS UNKNOWN IF THERE WAS A DELAY OR IF A BACKUP DEVICE WAS AVAILABLE AND HOW THE ISSUE WAS RESOLVED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Information

  MAUDE report 10168009 ↗
• InjuryJun 17, 2020Pumping Stopped; Pumping Stopped

  IT WAS REPORTED THAT WHEN THE SURGEON WENT TO USE PICO7 IN OR ALL ICON LIGHTS ILLUMINATED AND STAYED ON, SO THE DEVICE DID NOT WORK. THE PROCEDURE WAS COMPLETED WITH A COMPETITOR'S DEVICE AND THE CUSTOMER WOULD LIKE A REPLACEMENT.

  Patient problems: Injury

  MAUDE report 10165798 ↗